Targeted Oncology3h
FDA Grants 510(k) Clearance to Ibex Prostate Detect AI for Prostate Cancer
The FDA has granted a 510 (k) clearance to the Ibex Prostate Detect software (formerly Galen Second Read). The Ibex Prostate ...
MassDevice1h
Neuvotion wins FDA nod for neuromod wearable
Neuvotion announced today that it received FDA 510(k) clearance for its first product, the NeuStim wearable device.
TMCnet2h
Neuvotion Receives FDA Clearance for NeuStim™ Providing Non-Invasive, High-Resolution Stimulation for the Hand After Stroke or Spinal Cord Injury
Neuvotion has received FDA 510(k) clearance for their first product, NeuStim™, a non-invasive, surgery-free wearable that ...
Healio6d
FDA grants 510(k) clearance to AI Optics’ handheld retinal imaging system
The FDA has granted 510(k) clearance to AI Optics’ Sentinel Camera, a handheld retinal imaging system that captures ...
Ibex Medical Analytics Receives First FDA 510(k) Clearance
Ibex Medical Analytics (Ibex), the leader in AI-powered cancer diagnostics, today announced that it has received U.S. Food ...
Healio13d
FDA grants 510(k) clearance to stroke thrombectomy catheter system
The FDA has granted 510(k) clearance to a Bay Area commercial stage medical technology company for its novel large-bore ...
MassDevice6d
FDA clears AI 3D head, neck imaging tech from RapidAI
RapidAI announced that it received FDA 510(k) clearance for its Lumina 3D automated 3D imaging reconstruction solution.
Pharmabiz13h
AliveDx seeks US FDA 510(k) premarket approval for MosaiQ AiPlex CD multiplex microarray
AliveDx seeks US FDA 510(k) premarket approval for MosaiQ AiPlex CD multiplex microarray: Eysins, Switzerland Tuesday, February 11, 2025, 12:00 Hrs [IST] AliveDx, an established c ...
The Victoria Advocate13d
Roche receives FDA 510(k) clearance for the first blood test in the U.S. measuring Lp(a) in molar units
About the Tina-quant Lipoprotein (a) Gen.2 Molarity assay The FDA granted 510(k) clearance to the Tina-quant Lipoprotein (a) Gen.2 Molarity assay, which is useful in evaluating lipid metabolism ...
Joplin Globe8d
RapidAI Secures FDA 510(k) Clearance for Groundbreaking AI 3D Head and Neck CTA Imaging: Lumina 3D™
RapidAI, the global leader in AI-driven medical imaging analysis and coordinated care, has received FDA 510(k) clearance for Lumina 3D™ by RapidAI—an industry-first, automated 3D imaging ...